Important Update Regarding FDA Guidance for Industry (GFI) #256
Important Update Regarding FDA Guidance for Industry (GFI) #256
Important Update Regarding FDA Guidance for Industry (GFI) #256
We want to provide an important update regarding Food and Drug Administration's (FDA) Guidance for Industry (GFI) #256 and how it may impact compounded medication prescribing. Rood and Riddle Veterinary Pharmacy has dedicated significant resources to assist practitioners and clinics in navigating this landscape. We will be launching an improved digital platform, which includes a new website on May 27, 2026. We encourage you to use our new website, as it will guide you through the required steps and electronically capture all necessary additional information.
GFI #256 applies to compounding pharmacies preparing medications from Bulk Drug Substances (BDS) for:
- Patient-specific prescriptions for nonfood-producing animals
- Office stock medications for nonfood-producing animals. (Only in certain applicable states)
The primary focus of GFI #256 is compounded medications sold to veterinary practices as office-use medications. A secondary focus is on documentation requirements for patient-specific prescriptions when compounded medications are prescribed instead of commercially available FDA-approved products. Patient-specific dispensing has been our mainstay platform and the primary area covered by retail pharmacies.
What This Means for Veterinarians/Veterinary Clinics
When prescribing a patient-specific compounded medication, if there is an FDA-approved product available with:
- the same active ingredient
- the same route of administration
...the FDA expects documentation of a medical rationale explaining why the compounded preparation will provide a clinical difference or medical benefit for the patient.
Our pharmacy staff will be requesting this information during the original order entry and will become part of the medical record. In addition, there is a new order form online with some of the listed medical rationales.
Examples of Acceptable Medical Rationales Include:
- The commercial product would reduce compliance or be ineffective in achieving the desired medical outcome.
- The commercial product is unavailable, backordered, or unable to be sourced.